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A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

StatusRecruiting
PhasePhase 3
Started2024-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-07-27
minor
3 amendments v7-v9
3 re-verifications since 2026-04-21, no change to tracked fields
2026-02-02
minor
Study Status, Eligibility v6
Eligibility criteriarevised
[...] y CLIA certified testing method can be used. Clinical stage T0Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metast [...]
2025-08-28
minor
Study Status, Eligibility v5
Eligibility criteria+24 characters
[...] without evidence of distant metastasis based on FDG PET/CT. Upfront clarity in staging for both editions is needed to ensure eligibility. ECOG Performance Status of 0-1 or KPS >/=70 Age ≥ 18 Adequat [...] rovide study-specific informed consent prior to study entry Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic Exclusion Criteria: Patients with prior head and neck radiat [...]
2025-07-14
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 9 sites
2025-03-18
minor
Study Status, Contacts/Locations v3
Study sites7→9
2025-01-15
minor
2 amendments v1-v2
2 re-verifications since 2024-12-02, no change to tracked fields
2024-08-19
minor
Original filing
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
Trial Details
NCT Number NCT06563479
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions HPV-Related Squamous Cell Carcinoma
Enrollment 291 participants
Start Date 2024-08-19
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-24